Status:
RECRUITING
Exploratory Study on the Potential Cross-System Effects of BCI-FES Hand Therapy on Dysphagia and Aphasia in Chronic Stroke Patients
Lead Sponsor:
VASCage GmbH
Collaborating Sponsors:
g.tec medical engineering GmbH
Medical University Innsbruck
Conditions:
Ischaemic Stroke
Hemorrhagic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this neurorehabilitation explorative study is to investigate how a closed-loop Brain-Computer Interface Functional Electrical Stimulation (BCI-FES) therapy, used within the intended purpos...
Detailed Description
Stroke is the leading cause of permanent disability worldwide. Neurorehabilitation (i.e. physical, occupational, and speech/swallowing therapy) is essential for neurological recovery after stroke. Acc...
Eligibility Criteria
Inclusion
- Age: Participants must be aged 18 years or older.
- Post-Stroke Phase: Participants must be within the chronic post-stroke phase (time since ischemic or haemorrhagic stroke greater than 3 months).
- Motor Impairment: Participants must exhibit disabling left or right residual arm paresis ("left/right arm motor drift" part of the NIHSS score ≥1).
- Speech/Swallowing Impairment: Participants must have:
- Aphasia (AAT-Skala zum Kommunikationsverhalten score ≤3), and/or
- Dysphagia (MUCCS-N score ≥2).
- Stable Neurological Status: No relevant changes in neurological status in the past 4 weeks (self-reported).
- Motor Function: Participants must be able to raise at least 1 block similar to the ones in Box-and-Block-Test.
- Cognitive Understanding: Participants must be able to understand basic spoken instructions.
- Sitting Tolerance: Participants must be able to maintain a sitting position for at least 60 minutes.
- Willingness to Participate: Participants must be willing to participate in the study and able to understand and sign the informed consent.
Exclusion
- Cognitive Impairments: Cognitive impairments that, in the investigator's judgment, could limit understanding of task instructions.
- Stroke Location: Participants with a brainstem and/or cerebellar stroke.
- Previous Stroke: Participants with a previous disabling stroke.
- Hemi-Neglect: Pronounced hemi-neglect at the last documented therapy visit that limits compliance with treatment intervention (investigator's judgment).
- Anosognosia: Pronounced anosognosia at the last documented therapy visit that limits compliance with treatment intervention (investigator's judgment).
- Spasticity: Severe spasticity in the affected limb, resulting in complete rigidity in flexion or extension.
- Seizure Disorders: Participants with uncontrolled epilepsy (investigator's judgement) or epileptic seizure within the last month.
- Intracranial Pressure: Known ongoing elevated intracranial pressure.
- Implanted Medical Devices: Participants with implanted medical devices with contraindication for FES such as pacemakers.
- Metallic Fragments: Participants with implanted metallic fragments in the extremity planned for FES that would limit the use of functional electrical stimulation (FES).
- Unhealed Injuries: Unrecovered fractures or skin/tissue lesions in the FES stimulated extremity.
- Joint Issues: Ossification, contraction, or stiffness of the wrist joint in the FES stimulated extremity that would limit treatment.
- Botulinum Toxin: Participants who received botulinum-toxin treatment within 6 weeks prior to study inclusion and/or for whom botulinum-toxin treatment is planned during the study duration.
- Co-morbidities: The following conditions will exclude participation:
- Chronic Obstructive Pulmonary Disease (Stage IV).
- Cardiac insufficiency (NYHA Stage IV).
- Severe acute infections.
- Significant circulatory disturbances in the stimulated extremity.
- Sensory disorders that significantly impair the patient's ability to feel pain or react to unsuitable proprioceptive stimuli.
- Any other general medical conditions that, in the investigator's judgment, limit the safety or performance of study procedures (investigator's judgement).
- Electrical Stimulation Intolerance: Known inability to tolerate cutaneous electrical stimulation.
Key Trial Info
Start Date :
June 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06940635
Start Date
June 4 2025
End Date
June 30 2026
Last Update
November 26 2025
Active Locations (1)
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1
Department for Neurology, Medical University of Innsbruck
Innsbruck, Tyrol, Austria, 6020